Crimpable balloon stent protector

ABSTRACT

A protective sleeve for a catheter assembly comprising a tubular member composed of a first material. The first material having a first predetermined modulus of elasticity. The tubular member having at least one stripe of a second material engaged thereto. The second material having a greater modulus of elasticity than the first material. The tubular member having a loading state and being crimpable to a reduced state. In the loading state the tubular member being sized to disposingly engage the balloon of a catheter assembly wherein the balloon has a first diameter. When the tubular member is in the reduced state the tubular member is disposingly and retainingly engaged to the balloon. When the tubular member is in the reduced state the balloon has a second diameter which is less than the first diameter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application from application Ser. No.09/790,967, filed Feb. 22, 2001, the contents of which is herebyincorporated by reference

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

Not Applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to catheters having anexpandable balloon and to premounted balloon expandable stent ballooncatheters generally. More specifically, the present invention isdirected to dilatation balloon catheters having a removable protectivesheath which may reduce potential trauma caused to the stent and/or theballoon during a crimping process.

2. Description of Related Art

Percutaneous transluminal coronary angioplasty (PTCA) is a procedurewhich is well established for the treatment of blockages in the coronaryarteries. Blockages may occur from cholesterol precipitation on thecoronary wall which may be in any stage from initial deposit throughaged lesions. Coronary arteries may also become blocked due to formationof thrombus.

The most widely used form of percutaneous coronary angioplasty makes useof a dilatation balloon catheter. In typical PTCA procedures, thecardiovascular system of a patient is accessed with an introducer,usually in the groin area. All other devices including a guidingcatheter are percutaneously introduced into the cardiovascular system ofa patient through the introducer and advanced through a vessel until thedistal end thereof is at a desired location in the vasculature. A guidewire and a dilatation catheter having a balloon on the distal endthereof are introduced through the guiding catheter with the guide wiresliding through the dilatation catheter. The guide wire is firstadvanced out of the guiding catheter into the patient's coronaryvasculature and the dilatation catheter is advanced over the previouslyadvanced guide wire until the dilatation balloon is properly positionedacross the lesion. Once in position across the lesion, the flexible,expandable, preformed balloon is inflated to a predetermined size with afluid at relatively high pressures, such as greater than about fouratmospheres, to radially compress the atherosclerotic plaque of thelesion against the inside of the artery wall and thereby dilate thelumen of the artery. The balloon is then deflated to a small profile sothat the dilatation catheter may be withdrawn from the patientsvasculature and blood flow resumed through the dilated artery.

In angioplasty procedures of the kind described above, there may berestenosis of the artery, which either necessitates another angioplastyprocedure, a surgical by-pass operation, or some method of repairing orstrengthening the area. To reduce restenosis and strengthen the area, aphysician can implant an intravascular prosthesis for maintainingvascular patency, called a stent, inside the artery at the lesion. Ingeneral, stents are prosthetic devices which can be positioned within abody cavity, for example, a blood vessel of the body of a living humanor in some other difficulty accessible place. A stent generally has adiameter which may be increased or decreased. Stents are particularlyuseful for permanently widening a vessel which is in a narrowed state,or for internally supporting a vessel damaged by an aneurysm.

Such stents are typically introduced into the body cavity by use of acatheter. The catheter is usually of the balloon catheter type in whichthe balloon is utilized to expand the stent, which is positioned overthe balloon, to place it in a selected location in the body cavity. Thestent is expanded to a larger diameter for placement in the vasculature,often by the balloon portion of the catheter. Stents delivered to arestricted coronary artery, expanded to a larger diameter by a ballooncatheter, and left in place in the artery at the site of a dilatedlesion are shown in U.S. Pat. No. 4,740,207 to Kreamer and U.S. Pat. No.5,007,926 to Derbyshire.

In advancing an inflation expandable balloon through a body vessel tothe deployment site, the stent must be able to securely maintain itsaxial position on the delivery catheter, without trans-locatingproximally or distally, and especially without becoming separated fromthe catheter. Stents that are not properly secured or retained to thecatheter may slip and either be lost or be deployed in the wronglocation or partially deployed. In securing a stent to a catheter,however, the stent must be crimped in such a way as to minimize orprevent altogether distortion of the stent and to thereby preventabrasion and/or reduce trauma of the vessel walls.

In the past, crimping and balloon reduction has been done by hand oftenresulting in the application of undesired uneven forces to the stent.Such a stent must either be discarded or re-crimped. Stents which havebeen crimped multiple times can suffer from fatigue and may be scored orotherwise marked which can cause thrombosis. A poorly crimped stent canalso damage the underlying balloon.

Recently, stent crimping devices have been disclosed in U.S. Pat. No.5,546,646 to Williams et al, U.S. Pat. No. 5,183,085 to Timmermans etal., U.S. Pat. No. 5,626,604 to Cottone, Jr., U.S. Pat. No. 5,725,519,to Penner et al., U.S. Pat. No. 5,810,873 to Morales, WO 97/20593, WO98/19633 and copending U.S. app. Ser. No. 09/404986, filed Sep. 22, 1999to Klisch et al, the entire contents of each reference beingrespectively incorporated herein by reference.

One important characteristic of a dilatation balloon catheter as well asa stent delivery catheter is its “profile”, which is determined by theouter diameter (O.D.) of the distal end portion of the balloon and stentwhen deflated. The outer diameter affects the ease and ability of thedilatation catheter to pass through a guide catheter, through thecoronary arteries, and across a lesion. Considerable effort has beenmade in developing low profile dilatation balloon catheters. U.S. Pat.No. 5,342,307, incorporated herein by reference, discloses a balloonprotector sleeve used with a tri-fold dilatation balloon catheter forangioplasty. Because reduction of profile is of significance balloonreduction often includes the use of a first profile reducing “bi-tube”as well as one or more smaller balloon protectors. Typically the bi-tubeis placed about the balloon after the balloon is folded and wrapped. Thebi-tube is typically removed and replaced with one or more balloonprotectors suitable for retaining the balloon in the reducedconfiguration for shipment or storage. Such use of bi-tubes and balloonprotectors are also used in prior stent crimping processes as will bedescribed in greater detail below.

Minimization of “profile” is of importance in balloon catheters andstent delivery systems. In addition to securing the stent onto theballoon catheter, the crimping process may also provide the catheterwith a reduced profile configuration. Accordingly, the balloon protectorof the present invention is particularly directed for use with ballooncatheters and stent delivery systems wherein the protector provides theballoon and stent with protection during the crimping process, therebyallowing the stent to be safely secured to the balloon in a reducedprofile state.

All US patents, applications and all other published documents mentionedanywhere in this application are incorporated herein by reference intheir entirety.

BRIEF SUMMARY OF THE INVENTION

This invention is directed to a crimpable sheath or protector which maybe placed onto the balloon carrying portion of a catheter or stentdelivery system prior to reduction of the balloon and/or crimping of astent onto the balloon. The invention eliminates direct contact betweenthe crimping apparatus and the stent and/or balloon. The larger size andpotential surface area of the protector allows for minimization ofloading forces and allows the catheter to achieve an optimum profilewhile minimizing trauma to the underlying balloon and/or stent.

In at least one embodiment of the invention, the inventive balloonprotector may be characterized as a polymer sleeve or tube whichincludes at least one fiber or stripe of relatively rigid materialembedded into the polymer material. The fiber or fibers may beconfigured and oriented in any manner. For example: the fiber(s) may belongitudinally, radially, and/or helically, oriented relative to thelongitudinal axis of the protector. The fibers may also be braidedtogether to form a net like configuration. The fiber may be uniformlydispersed throughout the protector body or may be configured with avariety of uniform or non-uniform patterns of dispersion as may bedesired.

In at least one embodiment of the invention, the protector is employedwith a catheter having an expandable distal portion constructed andarranged for expanding the outer diameter of the catheter from acontracted state to an expanded state. The distal portion of thecatheter comprises a balloon which is folded or otherwise collapsed, andis expandable to an expanded condition. The balloon protector maycomprise a removable sleeve.

In at least one embodiment of the invention, the sleeve is constructedfrom at least two materials, wherein the second material ischaracterized as one or more strands of a rigid material or braids ofrelatively hard material suspended within or by the first material.

A description of the manufacture of a type of dual material sleeve maybe found in U.S. pat. app. Ser. No. 09/668496, filed Sep. 22, 2000, toYang as well as in the related U.S. pat. app. Ser. No. 09/716757, filedNov. 20, 2000, the entire contents of both references being incorporatedherein by reference.

The inside diameter of the protector is sized to allow for minimalloading force thereby allowing for ready insertion of the distal end ofthe balloon catheter into the protector. Because the protector issuitable for use with virtually any size of balloon catheter the innerdiameter may range from 0.5 mm to over 10.00 mm if desired. However,typically the protector will have an inner diameter of 0.75 mm to about5.0 mm.

In use the protector sleeve is positioned around the balloon, andoptionally over a stent, prior to reduction of the balloon or crimpingof the stent onto the balloon surface. Alternatively, the stent may alsobe loaded onto a reduced balloon after the protector has been placedthereon. The combined balloon/protector apparatus may then be insertedinto a stent crimping apparatus such as those described in thereferences cited above. Other crimping devices which may be used includebut are not limited to the TOMINATOR™ crimping device available fromMachine Solutions of Flagstaff, Ariz.

The protector prevents direct contact between the crimping apparatus andthe balloon as well as the stent. By preventing direct contact betweenthe crimper and stent, the protector of the present invention allowsstents having relatively fragile stent coatings, such as are known to beused in drug delivery applications to be crimped onto a balloon withoutcausing damage to the stent or the relatively delicate coatings. Someexamples of stents have drug delivery coatings are described in U.S.Pat. No. 5,972,027 and copending U.S. app. Ser. No. 09/420,094, filedOct. 18, 1999 to Johnson, the entire contents of both of which beingincorporated herein by reference.

After reduction or crimping of the catheter and protector, the protectorprovides a compressive force to retain the balloon in a reducedconfiguration. The protective sleeve is removed from the catheter priorto use of the catheter.

The present invention also provides for an improved process for applyinga balloon protector by providing a crimpable balloon protector whichdoes not require the use of a bi-tube for initial balloon preparation.As may be known, the application of many prior balloon protectorsrequire several steps. For example, applying a prior balloon protectormay require the following steps: Loading the bi-tube onto the shaft theof a balloon catheter, then folding the balloon into a desiredconfiguration followed by wrapping the folded balloon. The bi-tube isthen slid over the wrapped balloon. Next, the balloon and bi-tube areheat set during the curing process of the shaft coating of the catheter.Following the heat set process, the bi-tube is removed from the balloonand a the smaller diameter balloon protector is placed over the balloonin order to improve profile and to protect the balloon during shipmentand storage.

By providing a crimpable balloon protector as described herein, thepresent invention eliminates the need for a bi-tube and thus the processsteps associated with the bi-tube.

In at least one embodiment of the invention the, the invention providesfor an improved method for applying the present balloon protector to aballoon. At least one embodiment of the inventive method includesapplying the present balloon protector to a formed balloon. The combinedballoon and protector is then crimped. The crimping action reduced theprofile of the balloon and simultaneously wraps the balloon. Thecombination balloon and protector is now in condition for shipmentand/or storage. The protector remains on the balloon until the balloonis ready for use.

Similar to the process for applying a prior type of balloon protector,prior systems of crimping a stent onto a balloon and applying a stentprotector often require numerous steps. For example, a application of astent protector may require the following steps: folding the balloon,wrapping the balloon, sliding the bi-tube over the balloon, heat settingthe balloon, loading the stent onto the balloon, crimping the stent, andfinally loading a stent protector over the stent. By providing acrimpable stent protector, the present invention provides a stentprotector which may be placed over the stent prior to crimping. As aresult, the stent is protected during the crimping process as the bladesof the crimper are not able to directly.

In at least one embodiment of the invention a first crimpable balloonprotector may be applied to a balloon as described above. After crimpingthe balloon and protector, the balloon protector is removed from theballoon and a stent is loaded onto the balloon. A crimpable stentprotector may then be placed over the stent. The entire apparatus isthen crimped. The crimpable stent protector is removed prior to use ofthe stent delivery catheter.

In at least one embodiment of the invention the protective sleeve mayhave one or more slits along its length such as are described in U.S.Pat. No. 6,152,944.

In at least one embodiment of the invention the protective sleeve mayinclude one or more longitudinally oriented indentations or grooves.These indentations may be characterized as scoring on the inside,outside or both surfaces of the protector. The presence of scoringprovides additional flexibility to the protector and allows theprotector to be reduced in diameter, such as is caused by the crimpingprocess, without distorting the general shape of the protector. Theindentations may extend across the entire length of the protector andmay have a variety of shapes and configurations.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A detailed description of the invention is hereafter described withspecific reference being made to the drawings in which:

FIG. 1 is a perspective view of an embodiment of the invention;

FIG. 2 is a perspective view of the embodiment of the invention shown inFIG. 1 mounted an a catheter;

FIG. 3 is a perspective view of the embodiment of the invention shown inFIG. 1, wherein the protector is shown being removed from the catheter;

FIG. 4 is a perspective view of the embodiment of the invention shown inFIG. 1 mounted an a catheter, wherein the catheter includes a stent;

FIG. 5 is a perspective view of the embodiment shown in FIG. 4 whereinthe protector and catheter are shown being crimped;

FIG. 6 is a perspective view of an alternative embodiment of theinvention;

FIG. 7 is a perspective view of an alternative embodiment of theinvention;

FIG. 8 is a perspective view of an alternative embodiment of theinvention;

FIG. 9 is a cross-sectional view of an alternative embodiment of theinvention;

FIG. 10 is a cross-sectional view of the embodiment shown in FIG. 9,wherein the protector is shown in a reduced configuration; and

FIG. 11 is a perspective view of an alternative embodiment of theinvention.

FIG. 12 is a detailed partially cut-away view of a portion of theprotector shown in the embodiments of FIGS. 1-5.

DETAILED DESCRIPTION OF THE INVENTION

As may be seen in FIG. 1, the present invention is directed to aballoon/stent protector 10 which has a composite construction of atleast two materials. The protector sleeve 10 may be composed of a firstpolymeric material 11 which may be any flexible polymeric material suchas PE, PTFE, Nylon, Teflon, polyamide, and/or other suitable polymermaterial. Other materials form which the first material 11 may beselected include, but are not limited to: polyurethane-polyetherpolymers, such as Tecothane™ available from Thermedics, Inc.;polyester-polyurethanes, such as Pellethane™ sold by Dow Chemical;polyether-polyurethanes, such as Estane™ sold by BF Goodrich; polyetherblock amides, such as Pebax™ available from Elf Atochem; andstyrene-butadien-styrene triblock copolymers such as Kraton™ sold byShell Chemical company. Other materials which may also be used in theproduction of the first material 11 include, but are not limited tostyrenic block copolymers, polyurethanes, silicone rubber, naturalrubber, copolyesters, polyamides, EPDM rubber/polyolefin, nitrilrubber/PVC, fluoroelastomers, butyl rubber, epichlorohydrin,polyethylene, high density polyethylene (HDPE), and any combinationsthereof. Alternatively, the first material may also be woven fabric ormesh.

The first material 11 has one or more strands of a second material 13which is characterized as having a greater modulus of elasticity thanthe first material 11 imbedded or coextruded therewith. The secondmaterial 13 may be a polymer of a relatively hard nature when comparedto the first material 11. The second material 13 may be selected fromone or more of the following substances: metal, glass, carbon, and/orpolymers.

Where the material 13 includes a polymer, such polymer materials may bea liquid crystal polymer (LCP) such as VECTRA®, polyetheretherketone(PEEK) material, and PPS. Other materials may also be utilized as thefibril component of the present invention. Such substances includearomatic nylon, rigid polyurethane, polyester, copolyester, polyesterblends, polyester/polyurethane blends, PEEK, PPS, fluoropolymer and soon.

The material 13 may be characterized as a fiber and may include one ormore of the following substances: polyurethane-polyether polymers, suchas Tecothane™ available from Thermedics, Inc.; polyether-polyurethanes,such as Estane™ sold by BF Goodrich; polyether block amides, such asPebax™ available from Elf Atochem. Other materials which may also beused in the production of the second material 13 include, but are notlimited to: polyolefins, polystyrene, polyvinyl chloride,acrylonitrile-butadiene-styrene polymers, polyacrylonitrile,polyacrylate, vinyl acetate polymer, cellulose plastics, polyurethanes,polyethylene terephthalate, polyacetal, polyethers, polycarbonates,polyamides, polyphenylene sulfide, polyarylethersulfones,polyaryletherketones, polytetrafluoroethylene, and any combinationsthereof.

Other materials which may be suitable for use in forming the fibermaterial 13 include Nylon; Kevlar™; polyethyleneterephthalate (PET);metals such as: stainless steel, aluminum, NITINOL and others. Otherembodiments include the use of glass filled nylon and woven fabric ormesh. In addition, the second material 13, may be a combination ofrelatively hard materials. For example, the second material 13 may be awoven braid of multiple materials such as, NITINOL and stainless steel.

As depicted in FIG. 2, the unique construction of the protector 10allows the protector 10 to be placed about the balloon portion 14 of acatheter 16 and may then be subjected to crimping forces. Despite beingcrimped around the balloon 14, the protector 10 may be removed from theballoon 14 prior to insertion of the catheter 16 into a body lumen, suchas is shown in FIG. 3.

As may be seen in FIG. 4, the present protector 10 may also be utilizedto crimp a stent 18 onto a balloon 14 of the catheter 16. The protector10 is placed over the stent 18 before the stent is crimped. As may beseen in FIG. 5, the combination of the catheter 16, stent 18 andprotector 10 is inserted into a crimping device 20. Before crimping thestent 18 has a nominal diameter configuration and after crimping, thestent 18 has a reduced diameter configuration which is less than thenominal diameter configuration. The crimping forces are transmitted tothe stent 18 but the crimping blades 22 are prevented from contactingthe stent 18 due to the presence of the protector 10. The protector 10may be removed from the catheter 16 at any time after the crimpingprocess.

As previously indicated, the protector 10 is constructed from at leasttwo materials having different modulus of elasticity. The first material11 is formed into a generally tubular sleeve 24. In the embodiment shownin FIGS. 1-5, the second material 13 is embodied in at least one fiberor stripe of material 26. In the embodiment shown, the fiber 26 issubstantially parallel to the longitudinal axis 25 of the protector 10.

As indicated above, the first material 11 may be any elastic materialknown. The first material 11 has a modulus of elasticity less than thatof the second material 13. The second material 13 may be any materialthat when presented as one or more longitudinally oriented fibers has amodulus of elasticity greater than that of the first material 11.

The various substances which may be used to form the second material 13may be used singly or be combined in a wide variety of manners andconfigurations. Where the second material 13 is embodied as one or morefibers 26 such as is shown in FIGS. 1-5, each fiber 26 may be acombination of one or more materials 13 that may be woven or braidedtogether to form a braid 29, such as is shown in FIG. 12, or a singlecontinuous shaft of material or materials, such as a filament, wire orribbon of one or more of the materials 13 mentioned above. Otherconfigurations may also be provided, some of which are described ingreater detail below.

In addition, the manner in which the fiber(s) 26 are combined with thefirst material 11 may also vary. The fiber(s) 26 may be co-extruded withthe first material 11. The fiber(s) 26 may be imbedded into the firstmaterial 11, or may be placed over the first material 11. The fiber(s)26 may also be woven into the matrix of the first material 11.

The above examples of the combining of the first and second materials 11and 13 or the configurations of fiber(s) 26 or the various manners inwhich the fiber(s) 26 and first material 11 may be joined, are in no wayexhaustive of the potential substances or combinations of substanceswhich may be used. The present invention is directed to a sleeve 24composed of any materials which have the respective modulus ofelasticity qualities previously described for the respective materials11 and 13.

As may be seen in the various figures, the present invention may beembodied in a variety of manners. For instance, in the embodiment shownin FIG. 1 the protector 10 is shown with a plurality of substantiallyparallel longitudinally oriented fibers 26.

As may be seen in FIG. 6, the fibers 26 do not necessarily extend overthe entire length of the protector 10. In addition, the fibers 26 may beconfigured to have a variety of lengths, and may be spaced uniformly ornon-uniformly through out the first material 11.

In FIG. 7 an embodiment of the invention is shown wherein the secondmaterial 13 is distributed in a plurality of fibers 26 which have ahelical distribution about the sleeve 24 relative to the longitudinalaxis 25.

In FIG. 8 the protector 10 is shown wherein the first material 11 is ofa single uniform construction and the second material 13 is comprised ofa web 28 of interconnecting fibers 26 embedded therein.

In all of the various embodiments of the invention depicted and/ordescribed herein the protector 10 may be characterized as having aninside surface 30 and an outside surface 32. The inner and/or outersurfaces 30 and 32 may be entirely or selectively coated with alubricious coating such as may be known. The use of such a coating mayprovide the protector with the ability to be more readily retracted offof the stent 18 and or balloon 14.

As indicated above, the present balloon protector may be utilized forballoon reducing processes as well as stent crimping procedures. Wherethe protector is used to reduce a balloon the protector may be placeddirectly over a folded balloon. The protector and balloon may then becrimped which acts to wrap the balloon. If the balloon is to include astent, the crimped protector may be removed and the stent loaded intoplace. A second protector is inserted over the stent and balloon and theentire assembly is then crimped.

Whether the protector 10 is utilized for balloon reduction and/or stentcrimping, the protector 10 is capable of uniformly transmitting crimpingforces to the balloon 16 and/or stent 18. As may be seen in FIG. 9 theoutside surface 32 of the protector 10 is equipped with a plurality oflongitudinally oriented channels or scoring marks 36 which provide theprotector 10 with the ability to collapse in a uniform manner. In thepresent embodiment the marks 36 are scored out of the more flexiblefirst material 11 so that when the protector 10 is reduced by beingcrimped, the channels 36 close up upon themselves thereby reducing thediameter of the protector 10 in a substantially uniform manner such asis shown in FIG. 10. The channels 36 may be on the outside surface 32and/or the inside surface 30 as desired.

In an alternative embodiment shown in FIG. 11, the marks 36 arecharacterized as dimples or pores 38. When the protector 10 is in thereduced state described above, the dimples 38 will close up in a similarmanner.

In addition to being directed to the embodiments described above andclaimed below, the present invention is further directed to embodimentshaving different combinations of the features described above andclaimed below. As such, the invention is also directed to otherembodiments having any other possible combination of the dependentfeatures claimed below.

The above examples and disclosure are intended to be illustrative andnot exhaustive. These examples and description will suggest manyvariations and alternatives to one of ordinary skill in this art. Allthese alternatives and variations are intended to be included within thescope of the attached claims. Those familiar with the art may recognizeother equivalents to the specific embodiments described herein whichequivalents are also intended to be encompassed by the claims attachedhereto.

1. A catheter assembly comprising: a balloon; a stent, the stent beingdisposed about at least a portion of the balloon, the stent on theballoon defining a diameter, the diameter being crimped between anominal diameter configuration and a reduced diameter configuration lessthan the nominal diameter configuration; and a protective sleeve, theprotective sleeve being removably disposed about the balloon and stent,the protective sleeve comprising: a tubular member composed of a firstmaterial and at least one stripe of a second material engaged thereto,the second material characterized as being harder than the firstmaterial, the tubular member having a loading state and being crimpableto a crimped state, in the loading state the tubular member having afirst diameter and in the crimped state the tubular member having asecond diameter less than the first diameter, in the loading state thetubular member being disposed about the balloon and stent in the nominaldiameter configuration, in the crimped state the tubular memberretaining the balloon and the stent in the reduced profileconfiguration.
 2. The catheter assembly of claim 1 wherein the tubularmember comprises a longitudinal axis, the at least one stripe beingsubstantially parallel to the longitudinal axis.
 3. The catheterassembly of claim 1 wherein the tubular member Further comprises alongitudinal axis, the at least one stripe being helically disposedabout the longitudinal axis of the tubular member.
 4. The catheterassembly of claim 1 wherein the at least one stripe is Embedded in thefirst material.
 5. The catheter assembly of claim 1 wherein the firstmaterial further comprises a plurality of scoring marks, when thetubular member is crimped from the loading state to the crimped statethe scoring marks constructed and arranged to collapse upon themselves.6. The catheter assembly of claim 5 wherein the plurality of scoringmarks are characterized as a plurality of channels.
 7. The catheterassembly of claim 5 wherein the plurality of scoring marks arecharacterized as a plurality of pores.
 8. The catheter assembly of claim1 wherein the second material comprises a braid of Nitinol and stainlesssteel.
 9. The catheter assembly of claim 1 wherein the first materialand the Second material are co-extruded.
 10. The catheter assembly ofclaim 1 wherein the at least one stripe is a wire, the wire engaged tothe first material.
 11. The catheter assembly of claim 1 wherein the atleast one stripe comprises a plurality of stripes.
 12. The catheterassembly of claim 11 wherein the plurality of stripes areinterconnected.